Activities Report of the Generic Drug Program (FY 2017)
| GDUFA YEAR/Actions This Month | 16-Oct | 16-Nov | 16-Dec | 17-Jan | 17-Feb | 17-Mar | 17-Apr | 17-May | 17-Jun | 17-Jul | 17-Aug | 17-Sep | FY-2017 |
|---|
|
| Refuse to Receive (RTR) + | 9 | 8 | 24 | 17 | 19 | 7 | 8 | 12 | 6 | 9 | 11 | 12 | 142 |
| Withdrawals (all original ANDAs) | 9 | 16 | 11 | 14 | 22 | 16 | 8 | 24 | 30 | 13 | 29 | 22 | 214 |
| Approvals + | 54 | 59 | 56 | 51 | 61 | 62 | 57 | 77 | 88 | 68 | 60 | 70 | 763 |
| Tentative Approvals + | 16 | 12 | 19 | 14 | 11 | 19 | 9 | 19 | 12 | 14 | 17 | 12 | 174 |
| Complete Responses (CR) + | 151 | 150 | 144 | 143 | 136 | 190 | 112 | 98 | 87 | 82 | 155 | 155 | 1603 |
| Drug Master File Completeness Assessment (DMF CA) | 52 | 50 | 88 | 117 | 99 | 97 | 44 | 67 | 62 | 57 | 39 | 48 | 820 |
| GDUFA YEAR (Receipts)Submissions This Month | 16-Oct | 16-Nov | 16-Dec | 17-Jan | 17-Feb | 17-Mar | 17-Apr | 17-May | 17-Jun | 17-Jul | 17-Aug | 17-Sep | FY-2017 |
|---|
|
| Abbreviated New Drug Applications (ANDA) ++ | 108 | 81 | 235 | 57 | 58 | 197 | 75 | 66 | 67 | 73 | 73 | 216 | 1306 |
| CBE Supplements | 493 | 430 | 530 | 497 | 451 | 618 | 586 | 690 | 532 | 440 | 549 | 508 | 6324 |
| PAS Supplements | 43 | 27 | 38 | 30 | 24 | 57 | 65 | 29 | 40 | 24 | 23 | 15 | 415 |
| GDUFA YEAR (Receipts)Submissions This Month | 16-Oct | 16-Nov | 16-Dec | 17-Jan | 17-Feb | 17-Mar | 17-Apr | 17-May | 17-Jun | 17-Jul | 17-Aug | 17-Sep | FY-2017 |
|---|
|
| Controls +++ | 153 | 162 | 134 | 206 | 254 | 258 | 224 | 274 | 286 | 235 | 256 | 225 | 2667 |
| GDUFA Post CR Meeting Requests ++++ | 178 | 180 | 181 | 183 | 188 | 192 | 196 | 199 | 201 | 201 | 204 | 206 | |
| Post CR Meeting Requests this month | 2 | 2 | 1 | 2 | 5 | 4 | 4 | 3 | 2 | 0 | 3 | 2 | 30 |
NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems, including application status updates.
These numbers are not intended for Congressional reporting purposes.
* = This data requires additional verification and will be posted when available.
+ = Revised to reflect more accurate counting by our tracking systems. For example, RTRs revised to include both RTR due to failure to pay user fees and RTR due to technical reasons.
++ = Starting FY15, ANDA Original Receipts are reported as raw receipts (versus filed receipts).
+++ = Controls have been revised to count only those requests deemed appropriate for a control.
++++ = Cumulative and NOT specific to the month.